Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia

NCT01334723 | Completed Results

• 1 other identifier: 114482
• Study Type: observational
• Target: 35,032
• Locations: 0 countries
• Sites: N/A

Brief Summary

This retrospective study aims to quantify the relationship between 5-alpha-reductase inhibitor (5ARI) adherence / length of therapy and the likelihood of acute urinary retention (AUR) or prostate surgery in patients with benign prostatic hyperplasia (BPH) as well as the economic impact associated with these medical encounters. The Integrated Health Care Information Solutions (IHCIS) database will be utilized for this study (2000-2006).

Conditions

Prostatic Hyperplasia

Keywords

Benign prostatic hyperplasia, enlarged prostate, 5-alpha-reductase inhibitor, adherence, surgery, acute urinary retention

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70%

  Claims-based definition of acute urinary retention (AUR) and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio \[MPR\]) and risk of AUR or surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 70%.

  The 5 and a half year period from January 1, 2000 to June 30, 2006

• Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75%

  Claims-based definition of AUR and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio \[MPR\]) and risk of AUR and surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 75%.

  Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

• Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80%

  Claims-based definition of AUR and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio \[MPR\]) and risk of AUR and surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 80%.

  Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

Secondary Outcomes (5)

• Mean Length of 5-ARI Therapy

  Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

• Mean BPH-Related Costs for Participants With an MPR >=70% Versus <70%

  Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

• Mean BPH-Related Costs for Participants With an MPR >=75% Versus <75%

  Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

• Mean BPH-Related Costs for Participants With an MPR >=80% Versus <80%

  Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

• BPH-Related Costs for Every 30 Days of 5-ARI Therapy

  Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

Study Arms (2)

Acute Urinary Retention

This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.

Drug: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy; Drug: Non-adherent to 5ARI therapy

Prostate Surgery

This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.

Drug: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy; Drug: Non-adherent to 5ARI therapy

Interventions

Adherent with 5-alpha-reductase inhibitor (5ARI) therapy DRUG

Patient with BPH who are adherent to 5ARI therapy (Adherence will be calculated using a medication possession ratio (MPR); 3 MPR threshold values of 70%, 75%, and 80% will be evaluated.)

Also known as: Proscar® is a registered trademark of Merck, Avodart® is a registered trademark of GlaxoSmithKline

Acute Urinary Retention; Prostate Surgery

Non-adherent to 5ARI therapy DRUG

Patients with BPH non-adherent to 5ARI therapy (Adherence will be calculated using a MPR; 3 MPR threshold values of 70%, 75%, and 80% will be evaluated.)

Also known as: Proscar® is a registered trademark of Merck, Avodart® is a registered trademark of GlaxoSmithKline

Acute Urinary Retention; Prostate Surgery

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients aged 50 years or older with a diagnostic claim of BPH and prescription claim for a 5ARI for at least 60 days during the observation period. Patients will be required to be continuously eligible for 6 months prior to and at least 6 months after index date.

You may qualify if:

• Male
• aged 50 years or older
• a diagnostic claim of BPH
• prescription claim for a 5ARI for at least 60 days during the observation period.
• continuously eligible for 6 months prior to and at least 6 months after index date.

You may not qualify if:

• prostate cancer
• any prostate-related surgical procedure prior to index date

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

5-alpha Reductase Inhibitors; Therapeutics

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 13, 2011
• Study Start: April 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 30, 2017
• Results First Posted: November 28, 2011

Record last verified: 2017-05